Advanced Solid TumorPhase 1/2NCT06008366
A Phase 1/2 Study of 7MW3711 in Advanced Solid Tumors
A Phase 1/2 study testing 7MW3711 for injection in people with Advanced Solid Tumor, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 1 site in China.
Trial summary
7MW3711 is an antibody-drug conjugate(ADC) directed to a target wildly expressed on solid tumors. This is an open-label, multicenter, phase 1/2 study to evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of 7MW3711 in subjects with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- 7MW3711 for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 281 participants
- Where
- 1 siteChina
- Study dates
- 5 Sep 2023to 1 Feb 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Life expectancy of at least 3 months as assessed by the Investigator.
- Histologically or cytologically confirmed locally advanced or metastatic solid tumor, progressive after last treatment received and who progressed on or after standard therapies or intolerant to approved therapies or who lack of effient standard therapies.
- An archival tumor tissue sample(formalin-fixed paraffin-embedded (FFPE) tumor tissue block or at least 5 unstained slides) or a fresh tissue sample should be provided. If the tissue sample cannot be provided during dose escalation, enrollment into the study is allowed after discussion with the Investigator
- Measurable or evaluable disease by RECIST v1.1.
- Have adequate hematopoietic, renal and hepatic functions.
- Men or women willing to use adequate contraceptive measures throughout the study.
Who cannot join
- Have other prior malignancies within 3 years before the first administration.
- Known central nervous system metastatic disease or carcinomatous meningitis except for treated and stable brain metastases.
- Have significant, uncontrolled, or active cardiovascular disease.
- Known history of COPD, or intestinal lung disease, or other respiratory diseases requring inpatient treatments within 4 weeks prior to first administration.
- Have adverse events due to prior antitumor therapy not resolved to grade 1 or lower by NCI CTCAE V5.0.
- Have active infections requiring treatment within 14 weeks; have infection of HIV, active infection of HCV and HBV.
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- Prior treatment with an antibody drug conjugate (ADC) that consists of an topoisomerase I inhibitor.
- Prior treatment with B7-H3 targeted agents.
- Have received chemotherapy, immunotherapy, curative radiation within 3 weeks prior to the first administration or targeted molecular within 2 weeks prior to first administration. have received Chinese patent medicine or Chinese herbs of anti-tumor indications within 1 weeks prior to the first administration.
- Have received any systemic immunosuppressants within 2 weeks prior to the first administration except for topical corticosteroids.
- Have received any other investigational drugs or medical device within 4 weeks prior to the first administration.
- History of drug abuse including narcotic and psychiatric drugs within 12 months prior to screening.
- Pregnant, or nursing females.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ethics Committee of Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
剑 张, Doctor, 18017312991, syner2000@163.com
About this study
Official title: A Phase Ⅰ/Ⅱ Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of 7MW3711 in Subjects With Advanced Solid Tumors
7MW3711 is an antibody-drug conjugate(ADC) directed to a target wildly expressed on solid tumors. This is an open-label, multicenter, phase 1/2 study to evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of 7MW3711 in subjects with advanced solid tumors.
Read the detailed description
Two parts are included in this study. The part of dose escalation and dose expansion(part 1) will enrolled subjects with advanced solid tumors and is to evaluate the safety and tolerability and to determine the maximum tolerated dose and/or the recommend phase 2 dose(RP2D) of 7MW3711 in subjects with advanced solid tumors.
- Conditions
- Advanced Solid Tumor
- Being tested
- 7MW3711 for injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7MW3711 for injectionDrug
IV administration of 7MW3711, Q3W, 3 weeks a cycle
7MW3711 for injectionDrug
IV administration of 7MW3711, the dosage regimen including dosage and dosing frequency for cohort expansion is conformed on basis of the data in part 1
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation and dose expansion | Experimental | All subjects enrolled in the part of dose escalation and dose expansion will receive 7MW3711 by introvenous infusion Receives: Drug: 7MW3711 for injection |
| Cohort expansion | Experimental | All subjects enrolled in the part of cohort expansion will be treated by 7MW3711 will receive 7MW3711 by introvenous infusion Receives: Drug: 7MW3711 for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of the incidence of adverse events (AEs) (part 1)
Incidence and seriousness of adverse events (AEs) and serious adverse events (SAEs) by CTCAE version 5.0
Measured: approximately up to 16 cycles, 21 days a cycle
Identification of the MTD and /or RP2D of 7MW3711(part 1)
MTD(maximum tolerated dose) and /or RP2D(recommended phase II dose)of 7MW3711(part 1)
Measured: from Day1 to Day21 in cycle1 of part 1
Overall response rate (ORR) evaluated by investigators based on RECIST version 1.1 in selected solid tumors(part 2)
ORR:defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR)
Measured: approximately up to 2 years
Secondary outcomes (5)
overall response rate (ORR) (part1)
ORR:defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR) based on RECIST version 1.1
Measured: approximately up to 1 year
evaluation of the incidence of adverse events (AEs) (part 2)
Incidence and seriousness of adverse events (AEs) and serious adverse events (SAEs) by CTCAE version 5.0
Measured: approximately up to 2 years
evaluation of Peak Plasma Concentration (Cmax) of 7MW3711
Peak Plasma Concentration（Cmax）
Measured: approximately up to 2 years
evaluation of AUC of 7MW3711
Area under the plasma concentration versus time curve (AUC)
Measured: approximately up to 2 years
evaluation of t1/2 of 7MW3711
Half life time（t1/2）
Measured: approximately up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start5 Sep 2023
- Primary completion30 Aug 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by Mabwell (Shanghai) Bioscience Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 281 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06008366
- Sponsor's protocol ID
- 7MW3711-2023-CP101
- Status last verified
- Sep 2023
- First submitted
- 7 Aug 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅰ/Ⅱ Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of 7MW3711 in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06008366
- Acronym / sponsor ID
- 7MW3711-2023-CP101
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 281 participants (estimated)
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 23 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
7MW3711 is an antibody-drug conjugate(ADC) directed to a target wildly expressed on solid tumors. This is an open-label, multicenter, phase 1/2 study to evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of 7MW3711 in subjects with advanced solid tumors.
Detailed description
Two parts are included in this study. The part of dose escalation and dose expansion(part 1) will enrolled subjects with advanced solid tumors and is to evaluate the safety and tolerability and to determine the maximum tolerated dose and/or the recommend phase 2 dose(RP2D) of 7MW3711 in subjects with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose escalation and dose expansion | Experimental | Drug: 7MW3711 for injectionAll subjects enrolled in the part of dose escalation and dose expansion will receive 7MW3711 by introvenous infusion |
| Cohort expansion | Experimental | Drug: 7MW3711 for injectionAll subjects enrolled in the part of cohort expansion will be treated by 7MW3711 will receive 7MW3711 by introvenous infusion |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Life expectancy of at least 3 months as assessed by the Investigator.
- Histologically or cytologically confirmed locally advanced or metastatic solid tumor, progressive after last treatment received and who progressed on or after standard therapies or intolerant to approved therapies or who lack of effient standard therapies.
- An archival tumor tissue sample(formalin-fixed paraffin-embedded (FFPE) tumor tissue block or at least 5 unstained slides) or a fresh tissue sample should be provided. If the tissue sample cannot be provided during dose escalation, enrollment into the study is allowed after discussion with the Investigator
- Measurable or evaluable disease by RECIST v1.1.
Key exclusion criteria (13 listed)
- Have other prior malignancies within 3 years before the first administration.
- Known central nervous system metastatic disease or carcinomatous meningitis except for treated and stable brain metastases.
- Have significant, uncontrolled, or active cardiovascular disease.
- Known history of COPD, or intestinal lung disease, or other respiratory diseases requring inpatient treatments within 4 weeks prior to first administration.
- Have adverse events due to prior antitumor therapy not resolved to grade 1 or lower by NCI CTCAE V5.0.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 7MW3711 for injectionIV administration of 7MW3711, Q3W, 3 weeks a cycle | Drug | Dose escalation and dose expansion |
| 7MW3711 for injectionIV administration of 7MW3711, the dosage regimen including dosage and dosing frequency for cohort expansion is conformed on basis of the data in part 1 | Drug | Cohort expansion |
Primary outcome
evaluation of the incidence of adverse events (AEs) (part 1)
Time frame: approximately up to 16 cycles, 21 days a cycle
Incidence and seriousness of adverse events (AEs) and serious adverse events (SAEs) by CTCAE version 5.0
Identification of the MTD and /or RP2D of 7MW3711(part 1)
Time frame: from Day1 to Day21 in cycle1 of part 1
MTD(maximum tolerated dose) and /or RP2D(recommended phase II dose)of 7MW3711(part 1)
Overall response rate (ORR) evaluated by investigators based on RECIST version 1.1 in selected solid tumors(part 2)
Time frame: approximately up to 2 years
ORR:defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR)
5 secondary outcomes
overall response rate (ORR) (part1)
Time frame: approximately up to 1 year
evaluation of the incidence of adverse events (AEs) (part 2)
Time frame: approximately up to 2 years
evaluation of Peak Plasma Concentration (Cmax) of 7MW3711
Time frame: approximately up to 2 years
evaluation of AUC of 7MW3711
Time frame: approximately up to 2 years
evaluation of t1/2 of 7MW3711
Time frame: approximately up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 7MW3711 for injection in people with Advanced Solid Tumor, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jian Zhang, Ph.D (18017312991, syner2000@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluation of the incidence of adverse events (AEs) (part 1) (time frame: approximately up to 16 cycles, 21 days a cycle). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.